Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Isoxadifen-ethyl,

[Federal Register: May 26, 2004 (Volume 69, Number 102)]

[Rules and Regulations]

[Page 29882-29890]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr26my04-7]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0093; FRL-7355-8]

Isoxadifen-Ethyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes three tolerances for the combined residues of the herbicide safener isoxadifen-ethyl in or on rice, grain; rice, straw; and rice, hulls. Bayer CropScience (formerly Aventis CropScience) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective May 26, 2004. Objections and requests for hearings must be received on or before July 26, 2004.

ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket ID number OPP-2004-0093. All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket. Although listed in the

index, some information is not publicly available, i.e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: James Parker, Registration Division

[[Page 29883]]

(7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-0371; e-mail address: parker.james@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   A. Does this Action Apply to Me?

   You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

   Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

   Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

   Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

   Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

   This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

   B. How Can I Access Electronic Copies of this Document and Other Related Information?

   In addition to using EDOCKET (http://www.epa.gov/edocket/), you may

   access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180

   is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

2. Background and Statutory Findings

   In the Federal Registers of June 9, 1999 (64 FR 30997) (FRL-6082- 6), and June 30, 2000 (65 FR 40632) (FRL-6592-6), EPA issued notices pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9E5060) by Aventis CropScience, formerly AgrEvo USA, now doing business as Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. That notice included a summary of the petition prepared by the petitioner.

   The petition requested that 40 CFR 180.570 be amended by establishing tolerances for the combined residues of the herbicide safener isoxadifen-ethyl, (ethyl 5,5-diphenyl-2-isoxazoline-3- carboxylate) (CAS No. 163520-33-0) and its metabolites: 4,5-dihydro- 5,5-diphenyl-3-isoxazolecarboxylic acid and [beta]-hydroxy-[beta]- benezenepropanenitrile, in or on the following rice commodities: rice, grain; rice, straw; rice hulls; and rice bran at 0.10, 0.25, 0.50, and 0.80 parts per million (ppm), respectively. There were no comments received in response to the notice of filing.

   In the Federal Register of June 21, 2001 (66 FR 33179) (FRL-6786- 1), EPA established time-limited tolerances (expiring June 21, 2004) for isoxadifen-ethyl in or on rice commodities. Submission of the following data was required: Confined/field accumulation in rotational crops study; rice processed commodity study; successful petition method validation of the analytical enforcement method; and adequate storage stability data.

   Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .''

   EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL- 5754-7).

3. Aggregate Risk Assessment and Determination of Safety

   Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for combined residues of isoxadifen-ethyl (CAS No. 163520-33-0) and its metabolites: 4,5- dihydro-5,5-diphenyl-3-isoxazolecarboxylic acid and [beta]-hydroxy-

   [beta] -benezenepropanenitrile on rice commodities. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

   A. Toxicological Profile

   EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by isoxadifen ethyl as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed by the Agency are discussed in the Federal Register of June 21, 2001 (66 FR 33179) (FRL-6786-1). At that time the Agency considered the toxicity database to be complete. No additional toxicity studies have been submitted by the petitioner.

   B. Toxicological Endpoints

   The dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

   Three other types of safety or uncertainty factors may be used: ``Traditional uncertainty factors;'' the ``special FQPA safety factor;'' and the

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   ``default FQPA safety factor.'' By the term ``traditional uncertainty factor,'' EPA is referring to those additional uncertainty factors used prior to FQPA passage to account for database deficiencies. These traditional uncertainty factors have been incorporated by the FQPA into the additional safety factor for the protection of infants and children. The term ``special FQPA safety factor'' refers to those safety factors that are deemed necessary for the protection of infants and children primarily as a result of the FQPA. The ``default FQPA safety factor'' is the additional 10X safety factor that is mandated by the statute unless it is decided that there are reliable data to choose a different additional factor (potentially a traditional uncertainty factor or a special FQPA safety factor).

   For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 100 to account for interspecies and intraspecies differences and any traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor or the default FQPA safety factor is used, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of safety factor.

   For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

   A summary of the toxicological endpoints for isoxadifen-ethyl used for human risk assessment is shown in Table 1. of this unit:

   Table 1.--Summary of Toxicological Dose and Endpoints for Isoxadifen-ethyl for Use in Human Risk Assessment

   Dose Used in Risk Assessment, Exposure Scenario

   Interspecies and Special FQPA SF and LOC Study and Toxicological Intraspecies and any for Risk Assessment

   Effects Traditional UF

   Acute dietary (females 13-50 years of NOAEL = 15 milligrams/ Special FQPA SF = 1X Rat developmental study age)

   kilograms/day (mg/kg/ aPAD = acute RfD / LOAEL = 120 mg/kg/day day)

   Special FQPA SF = 0.15 based on bent scapula UF = 100............... mg/kg/day.

   in rat fetuses Acute RfD = 0.15 mg/kg/ day.

   Chronic dietary (all populations) NOAEL = 3.3 mg/kg/day Special FQPA SF = 1X 1-Year dog feeding UF = 100............... cPAD = chronic RfD / study, (co-critical) Chronic RfD = 0.033 mg/ Special FQPA SF =

   90-day dog feeding kg/day.

   0.033 mg/kg/day.

   study LOAEL = 6.1 mg/kg/day based on kidney histopathology in both sexes of dogs in both studies

   Short-term dermal, inhalation, and Dermal (or oral) study LOC for MOE = No neurotoxicity studies are available. However, no clinical signs of neurotoxicity were observed in the available toxicity studies conducted with isoxadifen-ethyl in rats, rabbits, or dogs, other than those neurotoxic clinical signs associated with agonal toxicity in these species.

   There was no evidence of enhanced susceptibility in the rabbit developmental study or the 2-generation rat reproduction study.

   In the developmental rat study, quantitative susceptibility was evidenced as increased fetal incidences of bent scapula at (120 mg/kg/day) a dose lower than that evoking maternal toxicity (mortality, reduced body weights, body weight gains, and food consumption at 1,000 mg/kg/day). The overall toxicity profile and the doses and endpoints selected for risk assessment for isoxadifen-ethyl, characterize the degree of concern for the effects observed in this study as low. There is a clear NOAEL and well-characterized dose response for the developmental effects observed. No residual uncertainties were identified. The NOAEL for developmental effects in this study (15 mg/kg/day) is used as the basis for the aRfD for the females 13-50 population subgroup. For all other toxicity endpoints established for isoxadifen-ethyl, a NOAEL lower than this developmental NOAEL is used.

   The residue chemistry and environmental fate databases are complete.

   The acute and chronic dietary food exposure assessments assumed tolerance level residues and 100% crop treated for all crops. Therefore dietary exposures/risks are unlikely to be underestimated.

   The drinking water assessment utilizes water concentration values generated by models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of drinking water concentrations.

   The residential assessment is considered a Tier I assessment. Therefore residential exposures/risks are unlikely to be underestimated.

   E. Aggregate Risks and Determination of Safety

   To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against EECs. DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water (e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure)). This allowable exposure through drinking water is used to calculate a DWLOC.

   A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the EPA's Office of Water are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. For isoxadifen-ethyl DWLOCs are calculated for: Acute, short-term, and chronic scenarios.

   When EECs for surface water and ground water are less than the

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   calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

   1. Acute risk. Using the exposure assumptions previously discussed in this unit for acute exposure, the acute dietary exposure from food to isoxadifen-ethyl will occupy 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open

      [[Page 29889]]

      from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603- 0061.

   2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.''

      EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001.

      If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

   3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number OPP-2004-0093, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

      B. When Will the Agency Grant a Request for a Hearing?

      A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

7. Statutory and Executive Order Reviews

   This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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8. Congressional Review Act

   The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

   List of Subjects in 40 CFR Part 180

   Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

   0 Therefore, 40 CFR chapter I is amended as follows:

   PART 180--[AMENDED]

   0 1. The authority citation for part 180 continues to read as follows:

   Authority: 21 U.S.C. 321(q), 346(a) and 371.

   0 2. Section 180.570 is amended by revising paragraph (a)(2) to read as follows:

   Sec. 180.570 Isoxadifen-ethyl; tolerances for residues.

   (a) * * *

   (2) Tolerances are established for the residues of isoxadifen-ethyl (3-isoxazolecarboxylic acid, 4,5-dihydro-5,5-diphenyl-, ethyl ester (CAS No. 163520-33-0)), and its metabolites 4,5-dihydro-5,5-diphenyl-3- isoxazolecarboxylic acid and [beta]-hydroxy-[beta]- benezenepropanenitrile when used as an inert ingredient (safener) in or on the following raw agricultural commodities, when applied at an annual application rate of 0.17 pounds isoxadifen-ethyl/acre.

   Commodity

   Parts per million

   Rice, grain..........................................

   0.10 Rice, hulls..........................................

   0.50 Rice, straw..........................................

   0.25

   * * * * *

   Dated: May 11, 2004. Lois Rossi, Director, Registration Division, Office of Pesticide Programs.

   [FR Doc. 04-11561 Filed 5-25-04; 8:45 am]

   BILLING CODE 6560-50-S